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Message about Newly Released DOXIL^®

(4/29/13)

Janssen Products, LP continues to release newly manufactured DOXIL^® (doxorubicin HCl liposome injection) under the regulatory discretion of the U.S. Food and Drug Administration (FDA).

Copies of our letters to healthcare professionals with additional details about each release of DOXIL^® can be found here. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.

How This Site Works and What You Can Expect

We've created DOXILSupply.com as an informational resource to share updates with patients, their loved ones and others about the DOXIL^® supply situation. This site complements the healthcare professional updates on our DOXIL^® website (www.doxil.com).

Our intent is to provide timely information about the DOXIL^® supply situation and what we're doing to address it. While we won't be able to address every question or statement made, our goal is to provide clarification and context about the supply situation. The site is not intended to discuss product matters of a more general nature.

Drug Manufacturing: A Complex Process

Manufacturing medicines can be a complex process and the production of chemotherapy products has special requirements. Producing chemotherapy drugs and sterile injectable medicines requires layers of complexity and production time. The process is made even more complex when additional steps, such as liposomal pegylation—the drug delivery system used by DOXIL^®—are involved.

A typical sterile, intravenous chemotherapy formulation requires only a few process vessels and one or two manufacturing steps, with batch completion typically taking a matter of hours. Creating the formulation for DOXIL^® requires 17 different process vessels, plus specialized equipment, requiring more time and adding complexity to the process. These proprietary DOXIL^® formulation steps are managed by specially trained personnel. These personnel must have specialized expertise for manufacturing DOXIL^® in addition to the training needed for manufacturing standard chemotherapies.

DOXIL(R) is specially coated to increase the time the drug is in the body and reaching the tissue

DOXIL^® is specially coated to increase the time the drug is in the body and reaching the tissue.

DOXIL^® is a specially coated form of doxorubicin that starts with the active agent, doxorubicin, and covers it with 2 layers of protective coating. This coating allows DOXIL^® to evade detection and destruction by the immune system, which increases the time the drug is in the body. As a result, DOXIL^® has more time to reach the tumor tissue, where the medication is slowly released. However, DOXIL^® may also affect normal tissue.

Put another way, this STEALTH^® Liposome technology gives the doxorubicin a shield, allowing it to better evade the body's immune system defenses.

Manufacturing is Just the Beginning...

Each batch of DOXIL^® takes at least 5 days to create, and once production is complete, it's just the beginning of the process to bring this medication to physicians and patients. Next, there are multiple steps to carefully review each batch and conduct tests. Each review requires time periods between tests to ensure the medication meets all US Food and Drug Administration (FDA) quality standards and requirements. And, the process of sampling and testing must happen in a specific order. Some of these tests are specific to drugs of a liposomal formulation.

Beyond the specialized equipment and process steps required to make DOXIL^®, special manufacturing expertise and facilities are needed to complete the entire process to specification. Given the unique requirements of the DOXIL^® production process, most chemotherapy manufacturers are not equipped to produce DOXIL^® and must build new in-house facilities and train staff to conduct each of the many steps required to make it. And, any new manufacturing facilities require further steps related to the development of new manufacturing suites. These additional requirements might include adding new equipment and tests to ensure the product being produced is exactly and precisely equivalent to DOXIL^®.
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INDICATIONS

DOXIL^® (doxorubicin HCl liposome injection) is used to treat patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy.

DOXIL^® is used with VELCADE^® (bortezomib) for Injection to treat patients with multiple myeloma who have received at least one prior therapy (other than VELCADE).

DOXIL^® is administered intravenously by your healthcare professional.

IMPORTANT SAFETY INFORMATION

Serious and possibly permanent heart-related side effects that may lead to congestive heart failure can occur in patients treated with DOXIL^®. Inform your doctor of any history of heart disease, radiation to your chest, or prior anticancer therapy. Your doctor will monitor your heart function.

Infusion reactions may also occur during administration. Be sure to tell your doctor if you have any symptoms during infusion, including: flushing, shortness of breath, facial swelling, headaches, chills, back pain, tightness in your chest or throat, dizziness, or lightheadedness. For most patients, these reactions have resolved within several hours to a day once the infusion is stopped, or for some patients with slowing of the infusion rate. However, in some cases, these reactions may be serious and sometimes life-threatening and may be fatal.

DOXIL^® may severely reduce the number of blood cells (red blood cells, white blood cells, and cells that prevent bleeding called platelets) in your body that may potentially increase risk of infections, anemia, and bleeding. Speak to your doctor if you notice any changes in your health. Your doctor will monitor your blood laboratory results.

Talk to your doctor if you have a history of heart disease or liver disease, or have received prior radiation therapy and/or anticancer therapy.

If you are pregnant, planning to become pregnant, or nursing inform your doctor. Nursing should be discontinued during treatment with DOXIL^®.

You should not take DOXIL^® if you have a prior history of allergic reactions to doxorubicin or other ingredients found in the formulation. Please inform your doctor about your history of allergic reactions to medications or other substances.

The most common side effects reported in at least 20% of patients treated with DOXIL^® during clinical studies were: weakness, fever, nausea, vomiting, stomatitis (painful redness, swelling, or sores in the mouth), diarrhea, and rash, loss of appetite, low white blood cell count, low platelet count, anemia, tiredness, and constipation. Hand-foot syndrome, which may lead to tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on palms of hands or soles of feet, was reported as well. In certain cases, this reaction can be more severe leading to serious infections, interfering with walking and other daily activities.

In the treatment of multiple myeloma, nerve damage called peripheral neuropathy, which may lead to pain, numbness, burning sensation, tingling, and more serious symptoms, was reported in >40% of patients.

Be sure to tell your doctor immediately if you experience any of these or other symptoms.

DOXIL^® may make the side effects of other anticancer therapies worse when used in combination.

Following administration, DOXIL^® may turn urine and other bodily fluids a reddish-orange color. This is due to the color of DOXIL^® and will go away as the drug leaves the body.

Your doctor may prescribe antinausea medications before or during your DOXIL^® treatment.

Please talk to your doctor or nurse if you have any additional questions regarding DOXIL^®.

For more information about DOXIL^® therapy, please visit www.DOXIL.com.

Please see full Product Information for more details.

VELCADE is a registered trademark of Millennium Pharmaceuticals, Inc.